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Agency: Food and Drug Administration

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The Federal Register
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1. Food Additives Permitted for Direct Addition to Food for Human Consumption; Acesulfame Potassium

RULES: Acesulfame potassium,

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of acesulfame potassium (ACK) as a generalpurpose sweetener and flavor enhancer in food, not including meat and poultry. This action
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is in response to a food additive petition filed by Nutrinova, Inc. It will simplify the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

2. Pediculicide Drug Products for Over-the-Counter Human Use; Amendment of Final Monograph

RULES: Pediculicide products (OTC); amendment of final monograph,

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for overthecounter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

3. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request;

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

4. Advisory Committees; Tentative Schedule of Meetings for 2004

NOTICES: Advisory committees; 2004 schedule,

The Food and Drug Administration (FDA) is announcing a tentative schedule of forthcoming meetings of its public advisory committees for 2004. During 1991, at the request of the Commissioner of Food and Drugs (the Commissioner), the Institute of Medicine (IOM) conducted a study of the use of FDA's advisory committees. In its final report, one of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

5. Biological Response Modifiers Advisory Committee; Notice of Meeting

NOTICES: Biological Response Modifiers Advisory Committee,

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Biological Response Modifiers Advisory Committee.

General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

6. Memorandum of Understanding Between the Food and Drug Administration, Department of Health and Human Services of the

NOTICES: Centers for Disease Control and Prevention and FDA; coordination and collaborative framework and information exchanges principles and procedures,

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Department of Health and Human Services of the United States of America and Swissmedic of the Swiss Confederation. The purpose of this MOU is to further enhance and strengthen communication and existing public
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

7. Memorandum of Understanding Between the Food and Drug Administration and the Health Products and Food Branch, Health

NOTICES: Health Products and Food Branch, Health Canada of Canada and FDA; enhance and stregthen exchange of information about therapeutic products,

The Food and Drug Administration is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration (FDA), Department of Health and Human Services of the United States of America and the Health Products and Food Branch, Health Canada of Canada. The purpose of this MOU is to enhance and strengthen the exchange of
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

8. Over-the-Counter Drug Products; Safety and Efficacy Review

NOTICES: Over-the-counter drug products; safety and efficacy review,

The Food and Drug Administration (FDA) is announcing a call for data for certain categories of ingredients in overthecounter (OTC) drug products that are eligible for the original OTC drug review but have not been reviewed by FDA to date. FDA will review the submitted data and information as part of its ongoing review of OTC drug products to
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

9. Exchange of Letters Between the Food and Drug Administration and the European Commission and the European Agency for

NOTICES: Pharmaceutical products intended for human or animal use; sharing documents and/or information between FDA and European Commission,

The Food and Drug Administration (FDA) is providing notice of an exchange of letters between FDA and the European Commission and the European Agency for the Evaluation of Medicinal Products (EMEA). The participants concluded this exchange of letters on September 12, 2003. These letters express the intentions of FDA, the European Commission, and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

10. Revision of the Requirements for Spore-Forming Microorganisms

RULES: Spore-forming microorganisms; performance requirements,

The Food and Drug Administration (FDA) is amending the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with spore forming microorganisms. FDA is amending the regulations due to advances in facility, system, and equipment design and in sterilization technologies that
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

11. Revision of the Requirements For Spore-Forming Microorganisms; Companion to Direct Final Rule

PROPOSED RULES: Spore-forming microorganisms; performance requirements,

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by providing options to the existing requirement for separate, dedicated facilities and equipment for work with sporeforming microorganisms. FDA is proposing this amendment due to advances in facility, system, and equipment design and in sterilization
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

12. Draft Guidance for Industry: Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing, Revision;

NOTICES: Clozapine tablets; in vivo bioequivalence and in vitro dissolution testing,

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing.'' This draft guidance provides recommendations for sponsors of abbreviated new drug applications (ANDAs) on the design of bioequivalence studies for generic
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

13. Advisory Committees; Filing of Annual Reports

NOTICES: Advisory committees; annual reports,

The Food and Drug Administration (FDA) is announcing, as required by the Federal Advisory Committee Act, that the agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2003.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

14. Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs

NOTICES: Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee,

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committees: Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee.

General Function of the Committee: To provide

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

15. Advisory Committee on Special Studies Relating to the Possible Long-Term Health Effects of Phenoxy Herbicides and

NOTICES: Ranch Hand Advisory Committee,

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: Advisory Committee on Special Studies Relating to the Possible LongTerm Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee).

DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

16. Guidance for Industry and FDA Staff; Premarket Notification Submissions for Chemical Indicators; Availability

NOTICES: Chemical indicators; premarket notification [510(k)] submissions,

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Premarket Notification [510(k)] Submissions for Chemical Indicators.'' The document provides guidance for industry and other interested parties regarding the submission of chemical indicators such as process indicators, chemical integrators, and air
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

17. Compliance Policy Guide Sec.110.300--``Registration of Food Facilities Under the Public Health Security and

NOTICES: Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002,

The Food and Drug Administration (FDA) is announcing the availability of a compliance policy guide (CPG) Sec. 110.300 entitled ``Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.'' The CPG provides written guidance to FDA's staff on enforcement of section 305 of the Public
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

18. Implantation or Injectable Dosage Form New Animal Drugs; Flunixin Meglumine Solution

RULES: Flunixin meglumine injectable solution,

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The ANADA provides for the veterinary prescription use of flunixin meglumine injectable solution for the control of inflammation in horses, beef cattle, and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

19. Agency Information Collection Activities; Comment Request; Guidance for Industry--Changes to an Approved New Drug

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

20. Neurological Devices; Classification of Human Dura Mater

RULES: Neurological devices—; Human dura matter; classification,

The Food and Drug Administration (FDA) is classifying human dura mater intended to repair defects in human dura mater into class II (special controls). This action is being taken to establish sufficient regulatory control to provide reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

21. Advisory Committee Information Hotline

NOTICES: Advisory Committee Information Hotline,

The Food and Drug Administration (FDA) is announcing that we have revised the Advisory Committee Information Hotline (the hotline). The hotline provides the public with access to the most current information available on FDA advisory committee meetings. This notice supersedes all previously published announcements of FDA's Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

22. Class II Special Controls Guidance Document: Human Dura Mater; Guidance for Industry and FDA; Availability

NOTICES: Medical devices—; Human dura matter; Class II special controls,

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Human Dura Mater.'' This guidance document describes a means
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by which human dura mater may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

23. Food and Cosmetic Security Guidances; Availability

NOTICES: Retail food stores and food service establishments and cosmetics processors and transponders; food and cosmetics security preventive measures,

The Food and Drug Administration (FDA) is announcing the availability of a guidance document related to food security entitled ``Retail Food Stores and Food Service Establishments: Food Security Preventive Measures Guidance'' (food security guidance) and a guidance document related to cosmetics security entitled ``Cosmetics Processors and
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

24. Guidance for Industry: Questions and Answers on the Interim Final Rule on Prior Notice of Imported Food; Availability

RULES: Food importation notice to FDA; industry guidance availability,

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Prior Notice of Imported Food, Questions and Answers.'' The guidance responds to various questions raised about the section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

25. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Requirements for

NOTICES: Agency information collection activities; proposals, submissions, and approvals,

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
DEPARTMENT OF HEALTH AND HUMAN SERVICES : Food and Drug Administration

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